Three Canadian Research Organizations Co-Defendants in Pradaxa Lawsuits in U.S.

Canada’s McMaster University and Hamilton Health Sciences are co-defendants in some of the more than two thousand lawsuits in U.S. federal court over the safety of the blood-thinning drug Pradaxa (dabigatran). The lawsuits allege that tainted data from clinical trials led by Hamilton researchers was used to gain approval of the drug in the United States and Canada.

Pradaxa, one of a trio of recently approved blood thinners, was welcomed by some heart specialists as a more convenient alternative to warfarin, the decades-old treatment for patients at risk of stroke because of atrial fibrillation, a common heart arrhythmia, according to The Spectator. Warfarin users must have regular blood testing and they are under dietary restrictions because warfarin interacts with certain foods and other medicines, according to the drug’s package insert. Pradaxa does not currently have these restrictions.

Nearly 2,300 Pradaxa users, or the estates of those who died, have filed suits against German pharmaceutical company Boehringer Ingelheim, alleging they were harmed by Pradaxa, The Spectator reports. McMaster University (in Hamilton, Ontario), Hamilton Health Sciences and the Population Health Research Institute are co-defendants in some of the cases. They ran the RE-LY trial, the only clinical trial involved in Pradaxa’s approval in the United States and Canada.

Federal judge David Herndon, who oversees the lawsuits, has selected four cases as bellwether cases, The Spectator reports. These representative cases will be the first ones tried and their outcomes could influence the resolution of the remaining cases.

Boehringer Ingelheim faces numerous allegations, including gross negligence, misrepresentation, product design defects, failure to warn patients, fraud, and fraudulent concealment. McMaster, HHS and the Population Health Research Institute (PHRI) face allegations of negligence, negligent misrepresentation, fraud and fraudulent concealment. Court documents say the organizations did not adequately design and administer the clinical trial, did not maintain trial data, and did not report serious adverse effects. “This is a safety issue, [and] it’s a public health issue,” an attorney for the plaintiffs told The Spectator. According to The New York Times, Pradaxa has been prescribed to some 850,000 patients and has been linked to more than 1,000 deaths.

Recently unsealed documents show that Boehringer Ingelheim attempted to suppress an internal study because the company worried the conclusions would damage Pradaxa sales. One of the company’s major marketing points is that Pradaxa does not require blood tests, but the study suggested that many Pradaxa users do need testing. Metabolic differences, especially in older users, may result in the patient absorbing too much or too little of the drug, The New York Times reported. With too little, the patient is not adequately protected against stroke, and with too much, the bleeding risk increases.